| CTRI Number |
CTRI/2025/03/083681 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the effect of Virechan Karma in Oxidative Stress |
|
Scientific Title of Study
|
Clinical study to evaluate the effect of Virechan Karma in Oxidative Stress w.s.r. to Jara Kricchen Labhte |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anil Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
ROOM NO. 203 PG Department of Panchkarma RGGPGACH
Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418466766 |
| Fax |
|
| Email |
anil5karma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
ROOM NO. 203 PG Department of Panchkarma RGGPGACH
Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418466766 |
| Fax |
|
| Email |
anil5karma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeet Kumar |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
Room No. 701 PG Department of Panchkarma RGGPGACH Paprola
Tehsil Baijnath District Kangra
Kangra
HIMACHAL PRADESH India
176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8628042100 |
| Fax |
|
| Email |
drsumeetksharele@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola Distt Kangra HP.
Charak Pharmacy Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital
Paprola District Kangra HP.
Research Institute in ISM Jogindarnagar District Mandi Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Prof Vijay Chaudhary |
| Address |
Principal cum Dean Room No 105 Admin Block Rajiv Gandhi
Government Postgraduate Ayurvedic College and Hospital, Paprola |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Anil Bhardwaj |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
Room Number 703
Department of
Panchkarma Rajiv
Gandhi Government
Postgraduate Ayurvedic
College and Hospital
Paprola District Kangra
HP
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418466766
anil5karma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola District Kangra Himachal Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: charak samhita kalpa sthana 1/5, Procedure details: 1.Deepan Pachan with trikatu churan for 3 days.
2.Snehpana with murchit goghrit for 3-7 days upto samyak snighdha lakshan
3.Sarvang Abhyang with moorchit til tail followed by sarvang Swedan for the next 3 days.
4.on next day after sarvang abhyang and sarvang swedan Virechan karma with virechan drug Haritkyadi Chooran.
5.Paschat karma including 1.Samsarjan Karama for 4,8,12 annakala upto 3,5,7 days.
2.Pariharya (Behavioural and Dietary restrictions)
)
(1) Medicine Name: Haritkyadi Churan, Reference: Charak Samhita Chikitsa Sthan 1/1/25-28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | placebo | placebo corn starch will be given in the capsule form of 500 mg in dose of 1 bd for the period of 18 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers fit for Virechan karma
Volunteers who sign the consent form for Virechan karma
|
|
| ExclusionCriteria |
| Details |
Volunteers contraindicated for Virechan Karma as per classics
Volunteers below 18 years and above 60 years of age
Volunteers having any associated chronic ailments like Tuberculosis, uncontrolled Hypertension, uncontrolled Diabetes Mellitus, and Malignancy.
Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Virechan karma in the
oxidative stress
To evaluate the effect of Virechan karma on Agni,
Indriyaprasadan, ManasBuddhi, Varna, Bala,
Vrishayta, Asyaprasadan, Lipid profile, BMI,
Protein level,
albumin and AG ratio, S. Calcium |
To check the efficacy of Virechan karma in the
oxidative stress
To evaluate the effect of Virechan karma on Agni,
Indriyaprasadan, ManasBuddhi, Varna, Bala,
Vrishayta, Asyaprasadan, Lipid profile, BMI,
Protein level,
albumin and AG ratio, S. Calcium |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore literature about jara and effect of
virechan karma in oxidative stress with special
reference to jara |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acharya Charaka mentioned in the indication of Shodhan Chikitsa that Jara can be delayed by administration of Shodhan chikitsa (Ch.Su.16/18) Acharya Charaka mentioned that before administration of Rasayana, Shodhan should be done. Therefore, we have selected Virechan Karma for this study. (Ch. K. 1/4; Ch.Chi.1/1/24) Modern lifestyle associated with processed food, incompatible food (Virudh Aahar), exposure to a wide range of chemicals & lack of physical activity due to advancement of science and technology, in long run all these factors can affect metabolic activity significantly. When body internal system fails to make balance between production and elimination of metabolic wastes (oxidized products of free radicals) at cellular level than body land into state of oxidative stress. O xidative stress has a role in a number of age-related disorders, including cancer, chronic renal disease, chronic obstructive pulmonary disease, and cardiovascular diseases (CVDs). Ageing is among the greatest known risk factors for most human diseases. Thus this study aims to evaluate the effect of Virechan karma on Agni, Indriyaprasadan, Manas- Buddhi, Varna, Bala, Vrishayta, Asyaprasadan, Lipid profile, BMI, Protein level,albumin and AG ratio, S. Calcium and Bio marker of oxidative stress and antioxidant activity i.e MDA (malondialdehyde) and GTH ( glutathione) respectively. 30 healthy volunteers will be selected as per Inclusion and Exclusion criteria. It will be an open trial. Selected volunteers will be divided randomly into two groups of 15 patients each. Group A will be managed with 1. Deepan Pachan with Trikatu churan for 3 days 2. Snehpana with Murchit Goghritta will be done for 3-7 days in increasing pattern depending upon Koshtha and Agni of the individual till the appearance of Samayak Snehpana Lakshana. 3. Sarvang Abhyang with Murchit Til Tail will be performed followed by Sarvanga Swedana. 4. Virechan Karma 5. Samsarjan krama Group B will be managed with Placebo of corn starch will be given in the capsule form of 500 mg in dose of 1 BD for the period of 18 days. |